PancreaticoduodenectomyNCT06322680
Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy
A study testing Main pancreatic duct and biliary duct external drainage and Main pancreatic duct and biliary duct internal drainage in people with Pancreaticoduodenectomy, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreaticoduodenectomy
- What is being tested?
- Main pancreatic duct and biliary duct external drainage and Main pancreatic duct and biliary duct internal drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteChina
- Study dates
- 24 May 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy ≥12 weeks and ASA score ≤2.
- Based on clinical symptoms, imaging examinations, tumor markers, and other auxiliary examinations, the clinical diagnosis includes but is not limited to tumors of the pancreatic head, ampulla of Vater, duodenum, and distal common bile duct, requiring pancreaticoduodenectomy.
- No serious dysfunction in blood system, heart, lung function, or autoimmune system (refer to the respective diagnostic criteria)
- White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb) ≥ 90 g/L
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- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2.5 × institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine (CRE) ≤ 1.5 × ULN
- Prothrombin time (PT) and international normalized ratio (INR) ≤ 1.5 × ULN
- Able to comply with research visit plans and other protocol requirements.
- With intermediate or high risk of postoperative pancreatic fistula (POPF) according to alternative fistula risk scoring system (A-FRS)
Who cannot join
- Cancer in late stage including distant organ metastasis (liver, lung, peritoneum), metastasis to the hilar bile duct and hepatic duct, extensive metastasis to the hepatic portal lymph nodes, tumor invasion of the superior mesenteric artery, celiac trunk, inferior vena cava, or abdominal aorta.
- Heart Failure: Congestive heart failure with New York Heart Association (NYHA) heart function classification of 3 or 4.
- Uncontrolled Hypertension:
- Renal Failure: Renal failure or insufficiency requiring hemodialysis or peritoneal dialysis.
- Active Infection: Serious active clinical infection (> Grade 2, NCI-CTCAE version 4.0).
- Pregnancy or Lactation: Pregnant or lactating women.
Show all 10Show fewer
- Major Surgery: Patients who have undergone major surgery within 4 weeks of starting the trial or have not recovered from the side effects of such surgery.
- Other Malignancies: Combined with other malignant tumors (patients who have been cured 3 years ago can be included).
- Upper Gastrointestinal Bleeding: Excluding patients with upper gastrointestinal bleeding within 4 weeks before surgery or with a clear tendency of gastrointestinal bleeding that cannot be corrected by active medical treatment.
- Poor Compliance: Poor compliance, unable or unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200000
Wen-Quan Wang, MD, PhD, +86 21 31587861, wang.wenquan@zs-hospital.sh.cn
About this study
Official title: The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy: A Multi-center Prospective Randomized Controlled Phase Clinical Trial
Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.
The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.
Read more
To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.
Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF.
Read the detailed description
Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.
The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.
To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.
Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF.
- Conditions
- Pancreaticoduodenectomy
- Being tested
- Main pancreatic duct and biliary duct external drainage, Main pancreatic duct and biliary duct internal drainage
- Keywords
- Pancreaticoduodenectomy, postoperative pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, biliary leakage
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Main pancreatic duct and biliary duct external drainageProcedure or surgery
Pancreaticojejunostomy:
Assess pancreatic texture and duct diameter, preparing a 2 cm pancreatic remnant, and securing it to the jejunum's muscular layer using 3-0 prolene for U-shaped anastomosis. A patented drainage tube is inserted into the jejunum for effective drainage. Anastomoses are performed with 4-0 prolene between the pancreatic duct and jejunal mucosa, both posteriorly and anteriorly, with additional reinforcement at the pancreas and jejunum's anterior walls. A Fr6 silicone tube is placed in the distal jejunal remnant and secured.
The drainage system, featuring a one-way valve, connects the internal and external silicone tubes to a drainage bag.
Choledochojejunostomy:
The common bile duct's diameter is noted, and an opening in the jejunum is made for hepatobiliary tract formation with 4-0 absorbable sutures. A Fr10 silicone tube is inserted into the afferent limb and secured. This tube, too, connects to the external drainage system with a one-way valve.
Main pancreatic duct and biliary duct internal drainageProcedure or surgery
Pancreaticojejunostomy:
Assess the pancreatic texture and pancreatic duct diameter, and reserve the length of the pancreatic remnant to about 1.5 cm. Open the transverse mesocolon and bring the distal small intestinal remnant to the side of the pancreatic remnant. Perform a 2 cm side-to-side pancreaticojejunostomy with an invagination technique. Use a simple full-layer suturing method, 4-0 PDS plus continuous suturing, insert a plastic strip into the pancreatic duct, and fix the pancreatic duct stent with 3/0 Vicryl.
Choledochojejunostomy:
Record the diameter of the common bile duct, about 10 cm away from the pancreaticojejunostomy, and open the jejunum. Form the hepatobiliary tract and perform interrupted anastomosis with 4-0 absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| Main pancreatic duct and biliary duct external drainage | Experimental | Pancreaticojejunostomy:
Assess pancreatic texture and duct diameter, preparing a 2 cm pancreatic remnant, and securing it to the jejunum's muscular layer using 3-0 prolene for U-shaped anastomosis. A patented drainage tube is inserted into the jejunum for effective drainage. Anastomoses are performed with 4-0 prolene between the pancreatic duct and jejunal mucosa, both posteriorly and anteriorly, with additional reinforcement at the pancreas and jejunum's anterior walls. A Fr6 silicone tube is placed in the distal jejunal remnant and secured.
The drainage system, featuring a one-way valve, connects the internal and external silicone tubes to a drainage bag.
Choledochojejunostomy:
The common bile duct's diameter is noted, and an opening in the jejunum is made for hepatobiliary tract formation with 4-0 absorbable sutures. A Fr10 silicone tube is inserted into the afferent limb and secured. This tube, too, connects to the external drainage system with a one-way valve. Receives: Procedure: Main pancreatic duct and biliary duct external drainage |
| Main pancreatic duct and biliary duct internal drainage | Experimental | Pancreaticojejunostomy:
Assess the pancreatic texture and pancreatic duct diameter, and reserve the length of the pancreatic remnant to about 1.5 cm. Open the transverse mesocolon and bring the distal small intestinal remnant to the side of the pancreatic remnant. Perform a 2 cm side-to-side pancreaticojejunostomy with an invagination technique. Use a simple full-layer suturing method, 4-0 PDS plus continuous suturing, insert a plastic strip into the pancreatic duct, and fix the pancreatic duct stent with 3/0 Vicryl.
Choledochojejunostomy:
Record the diameter of the common bile duct, about 10 cm away from the pancreaticojejunostomy, and open the jejunum. Form the hepatobiliary tract and perform interrupted anastomosis with 4-0 absorbable sutures. Receives: Procedure: Main pancreatic duct and biliary duct internal drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery
To evaluate the incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery. Medical record, outpatient visit, phone interview.
Measured: From date of surgery to postoperative day 90.
Secondary outcomes (12)
Surgical Complications: Incidence and grading of complications within 90 days after surgery
To evaluate the incidence of surgical complications mentioned above within 90 days after surgery. Medical record, outpatient visit, phone interview.
Incidence and grading of complications within 90 days after surgery:
Pancreatic fistula (A/B/C grade) Biliary fistula Chylothorax Gastrointestinal/intestinal anastomotic fistula Postoperative pancreatic hemorrhage Gastric emptying disorders Intra-abdominal infection Lower extremity deep vein thrombosis Pulmonary embolism Myocardial infarction Cerebral infarction Incisional complications
Measured: From date of surgery to postoperative day 90.
Surgical Complications: Clavien-Dindo classification
To evaluate the Clavien-Dindo classification within 90 days after surgery. Medical record, outpatient visit, phone interview.
Measured: From date of surgery to postoperative day 90.
Surgical Complications: Mortality rate
To evaluate the rate mentioned above within 90 days after surgery. Medical record, outpatient visit, phone interview
Measured: From date of surgery to postoperative day 90.
Surgical Complications: reoperation rate
To evaluate the rate mentioned above within 90 days after surgery. Medical record, outpatient visit, phone interview
Measured: From date of surgery to postoperative day 90.
Surgical Complications: readmission rate
To evaluate the rate mentioned above within 90 days after surgery. Medical record, outpatient visit, phone interview
Measured: From date of surgery to postoperative day 90.
Surgical Complications: rate of digital subtraction angiography for postoperative pancreatic hemorrhage
To evaluate the rate mentioned above within 90 days after surgery. Medical record, outpatient visit, phone interview
Measured: From date of surgery to postoperative day 90.
Surgical Complications: Total cost of perioperative treatment
To evaluate the total cost of perioperative treatment. Medical record.
Measured: From date of surgery to the date of discharge, an average of 2 weeks.
Surgical Complications: Length of hospital stay
To evaluate the length of hospital stay. Medical record.
Measured: From date of surgery to the date of discharge, an average of 2 weeks.
Adjuvant treatment: Proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery
To evaluate proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery. Medical record, outpatient visit, phone interview.
Measured: From date of surgery to the date of starting adjuvant treatment, an average of 1 month.
Adjuvant treatment: Interval between the start of adjuvant treatment and surgery
To evaluate the interval between the start of adjuvant treatment and surgery. Medical record, outpatient visit, phone interview.
Measured: From date of surgery to the date of starting adjuvant treatment, an average of 1 month.
Long-term survival related to malignant tumors: Overall survival (OS)
Overall survival after surgery. To evaluate the overall survival of patients after surgery. Outpatient visit, phone interview.
Measured: From date of surgery until the date of death from any cause, assessed 3 months thereafter up to 60 months
Long-term survival related to malignant tumors: Disease-free survival (DFS)
Disease-free survival after surgery. To evaluate the disease-free survival of patients after surgery. Outpatient visit, phone interview.
Measured: From date of surgery until the date of death from any cause, assessed 3 months thereafter up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start24 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PancreaticoduodenectomyStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Multicenter, Controlled, Superiority Trial
- Masking
- None (open label)
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, RenJi Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322680
- Sponsor's protocol ID
- ZSPAC-03
- Status last verified
- May 2024
- First submitted
- 8 Mar 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang WQ, Xu YL, Tang LH, He JY, Li Y, Liang F, Zhang YM, Gan W, Xu HX, Zhang L, Wu WC, Shi CY, Jin Y, Jiang CY, Wang Z, He M, Wang XA, Qiu YD, Liu L. Impact of external drainage of the main pancreatic duct and common bile duct on postoperative pancreatic fistula following pancreatoduodenectomy: protocol for a multicentre randomized clinical trial. BJS Open. 2025 Oct 30;9(6):zraf130. doi: 10.1093/bjsopen/zraf130.
PubMed 41189489
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of External Drainage of the Main Pancreatic Duct and Common Bile Duct on Pancreatic Fistula Following Pancreaticoduodenectomy: A Multi-center Prospective Randomized Controlled Phase Clinical Trial
- ClinicalTrials.gov ID
- NCT06322680
- Acronym / sponsor ID
- ZSPAC-03
- Conditions
- Pancreaticoduodenectomy
- Keywords
- Pancreaticoduodenectomy, postoperative pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, biliary leakage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Huadong Hospital, RenJi Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital Xi'an Jiaotong University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 24 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.
The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.
To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.
Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF.
Detailed description
Pancreaticoduodenectomy (PD) is the standard treatment for tumors of the pancreatic head, distal bile duct, duodenum, and ampulla of Vater. With advances in surgical experience and instrumentation, the mortality rate of PD has decreased to below 5% in high-volume pancreatic centers. However, the postoperative complication rate remains high at 25%-50%, limiting the development and application of PD.
The main postoperative complications of PD are postoperative pancreatic fistula (POPF), delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and biliary leakage (BL). POPF, BL, and the subsequent abdominal infection, PPH, etc. are the main causes of death during hospitalization. Even in large, relatively mature pancreatic centers, the incidence of POPF remains as high as 10%-40%. In recent years, various methods have been used to prevent and treat POPF and BL after PD, such as pancreatic duct stent external drainage and external biliary drainage.
To date, there have been many studies by domestic and foreign scholars on the advantages and disadvantages of biliary and pancreatic duct external drainage versus internal drainage in PD in terms of perioperative POPF incidence, mortality rate, etc., but the research results are not consistent. Overall, pancreatic duct stent external drainage is only recommended for patients with a high risk of pancreatic fistula during PD. Currently, there have been a few relevant studies exploring and verifying the preventive effect of pancreatic duct stent external drainage on pancreatic fistula in patients with high risk of pancreatic fistula. For example, a retrospective study of 98 patients with soft pancreatic parenchyma by Teruyuki Usub et al. found that there was no significant difference between groups with and without pancreatic duct stent in preventing pancreatic fistula. However, due to the low level of evidence, only a few risk factors such as pancreatic texture and pancreatic duct diameter were included, and the risk of POPF was not systematically evaluated. Further clinical exploration and verification are needed. In 2013, Mark P Callery et al. proposed a pancreatic fistula risk score (The fistula risk score, FRS) based on the pancreatic fistula standard defined by the International Pancreatic Fistula Study Group, which included pancreatic texture, pathological type, pancreatic duct diameter, and intraoperative blood loss. This model can be used to systematically and quantitatively evaluate the risk of POPF. Previous studies did not have a clear stratification for patients undergoing pancreatic duct stent external drainage, which may have included too many patients with a low risk of pancreatic fistula, resulting in inaccurate results. Therefore, it is necessary to re-evaluate the effectiveness of pancreatic duct stent external drainage in preventing clinically relevant pancreatic fistula based on stratification of pancreatic fistula risk and disease type. At the same time, pancreatic juice contains a variety of digestive enzymes, of which pancreatic lipase, trypsin, and chymotrypsin all need to be activated by bile to play a role in digesting and decomposing fat and protein. Theoretically, biliary and pancreatic juice diversion may be able to reduce the incidence of pancreatic fistula and its related complications in PD patients.
Thus, the investigators design the present study to evaluate the impact of main pancreatic duct and biliary duct external drainage on postoperative complication, especially POPF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Multicenter, Controlled, Superiority Trial
| Arm | Type | Receives |
|---|---|---|
| Main pancreatic duct and biliary duct external drainage | Experimental | Procedure: Main pancreatic duct and biliary duct external drainagePancreaticojejunostomy: Assess pancreatic texture and duct diameter, preparing a 2 cm pancreatic remnant, and securing it to the jejunum's muscular layer using 3-0 prolene for U-shaped anastomosis. A patented drainage tube is inserted into the jejunum for effective drainage. Anastomoses are performed with 4-0 prolene between the pancreatic duct and jejunal mucosa, both posteriorly and anteriorly, with additional reinforcement at the pancreas and jejunum's anterior walls. A Fr6 silicone tube is placed in the distal jejunal remnant and secured. The drainage system, featuring a one-way valve, connects the internal and external silicone tubes to a drainage bag. Choledochojejunostomy: The common bile duct's diameter is noted, and an opening in the jejunum is made for hepatobiliary tract formation with 4-0 absorbable sutures. A Fr10 silicone tube is inserted into the afferent limb and secured. This tube, too, connects to the external drainage system with a one-way valve. |
| Main pancreatic duct and biliary duct internal drainage | Experimental | Procedure: Main pancreatic duct and biliary duct internal drainagePancreaticojejunostomy: Assess the pancreatic texture and pancreatic duct diameter, and reserve the length of the pancreatic remnant to about 1.5 cm. Open the transverse mesocolon and bring the distal small intestinal remnant to the side of the pancreatic remnant. Perform a 2 cm side-to-side pancreaticojejunostomy with an invagination technique. Use a simple full-layer suturing method, 4-0 PDS plus continuous suturing, insert a plastic strip into the pancreatic duct, and fix the pancreatic duct stent with 3/0 Vicryl. Choledochojejunostomy: Record the diameter of the common bile duct, about 10 cm away from the pancreaticojejunostomy, and open the jejunum. Form the hepatobiliary tract and perform interrupted anastomosis with 4-0 absorbable sutures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Life expectancy ≥12 weeks and ASA score ≤2.
- Based on clinical symptoms, imaging examinations, tumor markers, and other auxiliary examinations, the clinical diagnosis includes but is not limited to tumors of the pancreatic head, ampulla of Vater, duodenum, and distal common bile duct, requiring pancreaticoduodenectomy.
- No serious dysfunction in blood system, heart, lung function, or autoimmune system (refer to the respective diagnostic criteria)
Key exclusion criteria (10 listed)
- Cancer in late stage including distant organ metastasis (liver, lung, peritoneum), metastasis to the hilar bile duct and hepatic duct, extensive metastasis to the hepatic portal lymph nodes, tumor invasion of the superior mesenteric artery, celiac trunk, inferior vena cava, or abdominal aorta.
- Heart Failure: Congestive heart failure with New York Heart Association (NYHA) heart function classification of 3 or 4.
- Uncontrolled Hypertension:
- Renal Failure: Renal failure or insufficiency requiring hemodialysis or peritoneal dialysis.
- Active Infection: Serious active clinical infection (> Grade 2, NCI-CTCAE version 4.0).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Main pancreatic duct and biliary duct external drainagePancreaticojejunostomy: Assess pancreatic texture and duct diameter, preparing a 2 cm pancreatic remnant, and securing it to the jejunum's muscular layer using 3-0 prolene for U-shaped anastomosis. A patented drainage tube is inserted into the jejunum for effective drainage. Anastomoses are performed with 4-0 prolene between the pancreatic duct and jejunal mucosa, both posteriorly and anteriorly, with additional reinforcement at the pancreas and jejunum's anterior walls. A Fr6 silicone tube is placed in the distal jejunal remnant and secured. The drainage system, featuring a one-way valve, connects the internal and external silicone tubes to a drainage bag. Choledochojejunostomy: The common bile duct's diameter is noted, and an opening in the jejunum is made for hepatobiliary tract formation with 4-0 absorbable sutures. A Fr10 silicone tube is inserted into the afferent limb and secured. This tube, too, connects to the external drainage system with a one-way valve. | Procedure or surgery | Main pancreatic duct and biliary duct external drainage |
| Main pancreatic duct and biliary duct internal drainagePancreaticojejunostomy: Assess the pancreatic texture and pancreatic duct diameter, and reserve the length of the pancreatic remnant to about 1.5 cm. Open the transverse mesocolon and bring the distal small intestinal remnant to the side of the pancreatic remnant. Perform a 2 cm side-to-side pancreaticojejunostomy with an invagination technique. Use a simple full-layer suturing method, 4-0 PDS plus continuous suturing, insert a plastic strip into the pancreatic duct, and fix the pancreatic duct stent with 3/0 Vicryl. Choledochojejunostomy: Record the diameter of the common bile duct, about 10 cm away from the pancreaticojejunostomy, and open the jejunum. Form the hepatobiliary tract and perform interrupted anastomosis with 4-0 absorbable sutures. | Procedure or surgery | Main pancreatic duct and biliary duct internal drainage |
Primary outcome
The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery
Time frame: From date of surgery to postoperative day 90.
To evaluate the incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery. Medical record, outpatient visit, phone interview.
12 secondary outcomes
Surgical Complications: Incidence and grading of complications within 90 days after surgery
Time frame: From date of surgery to postoperative day 90.
Surgical Complications: Clavien-Dindo classification
Time frame: From date of surgery to postoperative day 90.
Surgical Complications: Mortality rate
Time frame: From date of surgery to postoperative day 90.
Surgical Complications: reoperation rate
Time frame: From date of surgery to postoperative day 90.
Surgical Complications: readmission rate
Time frame: From date of surgery to postoperative day 90.
Surgical Complications: rate of digital subtraction angiography for postoperative pancreatic hemorrhage
Time frame: From date of surgery to postoperative day 90.
Surgical Complications: Total cost of perioperative treatment
Time frame: From date of surgery to the date of discharge, an average of 2 weeks.
Surgical Complications: Length of hospital stay
Time frame: From date of surgery to the date of discharge, an average of 2 weeks.
Adjuvant treatment: Proportion of patients with delayed adjuvant treatment (≥12 weeks) due to complications such as pancreatic fistula after surgery
Time frame: From date of surgery to the date of starting adjuvant treatment, an average of 1 month.
Adjuvant treatment: Interval between the start of adjuvant treatment and surgery
Time frame: From date of surgery to the date of starting adjuvant treatment, an average of 1 month.
Long-term survival related to malignant tumors: Overall survival (OS)
Time frame: From date of surgery until the date of death from any cause, assessed 3 months thereafter up to 60 months
Long-term survival related to malignant tumors: Disease-free survival (DFS)
Time frame: From date of surgery until the date of death from any cause, assessed 3 months thereafter up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Derived from this study: PubMed 41189489Wang WQ, Xu YL, Tang LH, He JY, Li Y, Liang F, Zhang YM, Gan W, Xu HX, Zhang L, Wu WC, Shi CY, Jin Y, Jiang CY, Wang Z, He M, Wang XA, Qiu YD, Liu L. Impact of external drainage of the main pancreatic duct and common bile duct on postoperative pancreatic fistula following pancreatoduodenectomy: protocol for a multicentre randomized clinical trial. BJS Open. 2025 Oct 30;9(6):zraf130. doi: 10.1093/bjsopen/zraf130.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Main pancreatic duct and biliary duct external drainage and Main pancreatic duct and biliary duct internal drainage in people with Pancreaticoduodenectomy, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of clinically relevant postoperative pancreatic fistula (B/C grade fistula) within 90 days after surgery (time frame: From date of surgery to postoperative day 90.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06322680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.